BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CROSSPOINT TRANSACCESS CATHETER

    K Number: K013363 · Decision Apr 2, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    398
    Registration Numbers
    399
    Same Product Code
    408
    Applicant Total
    2
    Review Days
    174

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    Basic Information

    Device Name
    CROSSPOINT TRANSACCESS CATHETER
    K Number
    K013363
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1570
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Trans Vascular Incorporated
    Date Received
    October 10, 2001
    Decision Date
    April 2, 2002
    Product Code
    ITX
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ITX Transducer, Ultrasonic, Diagnostic

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    Other Clearances by Trans Vascular Incorporated

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